A Study to Evaluate the Effectiveness and Tolerance of Two Acne Treatments on Subjects With Mild to Moderate Acne.
| Status: | Completed |
|---|---|
| Conditions: | Acne, Acne, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 12 - 40 |
| Updated: | 1/25/2018 |
| Start Date: | March 31, 2016 |
| End Date: | August 31, 2016 |
A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne Treatments on Subjects With Mild to Moderate Acne Vulgaris
This study will compare two different acne treatments for the treatment of acne. Half of the
participants will receive two marketed acne products (cleanser and leave-on topical
treatment), while the other half of the participants will receive a marketed cleanser and a
light-therapy device.
participants will receive two marketed acne products (cleanser and leave-on topical
treatment), while the other half of the participants will receive a marketed cleanser and a
light-therapy device.
Acne is a common chronic skin disease involving blockage and/or inflammation of the hair
follicles and their accompanying sebaceous gland.
Benzoyl peroxide (BPO) is one of the most effective and well-studied over-the-counter (OTC)
acne therapies, is generally regarded as safe and effective and is considered as a first-line
treatment for acne. Topical BPO monotherapy products for at-home acne treatment have been
available for OTC use for more than 30 years and studies have indicated that a low dose of
BPO may be an effective approach for treating acne using an OTC product when applied
consistently to larger areas of the face due primarily to its effects against acne-causing
bacteria.
BPO has anti-inflammatory and keratolytic properties, but is thought to act primarily to
control P. acnes by releasing reactive oxygen species that are toxic to the bacteria. The
most common side effect of topical BPO treatment is skin irritation, which can include
erythema, burning, and peeling.
As an alternative to topical OTC standard of care therapies, research has also shown the
benefits of red and blue light therapy in the treatment of mild to moderate acne, with red
and blue light shown to target the acne-causing bacteria and have an effect on inflammation
reduction.
Light-based therapies have been successfully used to treat dermatological conditions since
the early 1900's, with various parts of the electromagnetic spectrum (i.e. UV, visible,
near-Infrared, etc.) demonstrating different benefits. Light-emitting diodes (LEDs) offer
delivery of light to the skin in a gentler manner as compared to light delivered by lasers
primarily due to the lower energy output. It has been reported that LEDs do not deliver
enough power to damage tissues and do not have the same risk of accidental eye damage that
lasers do. Visible-LED light therapy has been deemed a non-significant risk by the Food and
Drug Administration and has been approved for use in humans.
This study will look to compare the acne clearing efficacy and tolerance of two different
acne treatments: a currently marketed 2.5% BPO full-face topical OTC treatment, and an
Investigational red and blue light acne light therapy mask, to determine if the acne
resolution efficacy of the Investigational mask is as effective as a current OTC standard of
care for at-home treatment of mild to moderate acne.
follicles and their accompanying sebaceous gland.
Benzoyl peroxide (BPO) is one of the most effective and well-studied over-the-counter (OTC)
acne therapies, is generally regarded as safe and effective and is considered as a first-line
treatment for acne. Topical BPO monotherapy products for at-home acne treatment have been
available for OTC use for more than 30 years and studies have indicated that a low dose of
BPO may be an effective approach for treating acne using an OTC product when applied
consistently to larger areas of the face due primarily to its effects against acne-causing
bacteria.
BPO has anti-inflammatory and keratolytic properties, but is thought to act primarily to
control P. acnes by releasing reactive oxygen species that are toxic to the bacteria. The
most common side effect of topical BPO treatment is skin irritation, which can include
erythema, burning, and peeling.
As an alternative to topical OTC standard of care therapies, research has also shown the
benefits of red and blue light therapy in the treatment of mild to moderate acne, with red
and blue light shown to target the acne-causing bacteria and have an effect on inflammation
reduction.
Light-based therapies have been successfully used to treat dermatological conditions since
the early 1900's, with various parts of the electromagnetic spectrum (i.e. UV, visible,
near-Infrared, etc.) demonstrating different benefits. Light-emitting diodes (LEDs) offer
delivery of light to the skin in a gentler manner as compared to light delivered by lasers
primarily due to the lower energy output. It has been reported that LEDs do not deliver
enough power to damage tissues and do not have the same risk of accidental eye damage that
lasers do. Visible-LED light therapy has been deemed a non-significant risk by the Food and
Drug Administration and has been approved for use in humans.
This study will look to compare the acne clearing efficacy and tolerance of two different
acne treatments: a currently marketed 2.5% BPO full-face topical OTC treatment, and an
Investigational red and blue light acne light therapy mask, to determine if the acne
resolution efficacy of the Investigational mask is as effective as a current OTC standard of
care for at-home treatment of mild to moderate acne.
Inclusion Criteria:
- Has mild to moderate acne
- Has 10 - 100 pimples, 10 - 50 inflamed red pimples, up to 2 raised bumps and no cysts
- In general good health
- Must avoid excessive sun exposure and any light treatments or any professional or
aesthetic spa-like procedures
- Must not be pregnant, nursing or intend to become pregnant during the study
- Must agree to practice a medically acceptable form of birth control.
- Must be able to read, speak, write and understand English
Exclusion Criteria:
- Allergies or sensitivities to product ingredients or to light
- Has severe acne or pre-existing dermatological facial condition
- Has an uncontrolled disease or immune deficient disorder
- Is pregnant, breast-feeding or intending to become pregnant
- Has been taking prescription drug medication for acne or antibiotics for the past 6
months
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